Navigation Links
FDA: Don't Buy Drugs Marketed as Antimicrobial Dietary Supplements

SILVER SPRING, Md., May 13, 2011 /PRNewswire-USNewswire/ --  The following was released today by the FDA:


Fast Facts

  • The FDA is warning consumers not to use products marketed as dietary supplements that also claim to be antimicrobial (antibiotic, antifungal or antiviral) drugs. These illegal products are falsely promoted with claims to treat illnesses such as upper respiratory infections, sinusitis, pneumonia, bronchitis and the common cold.
  • The FDA has learned that several companies are distributing and promoting products labeled as dietary supplements for antimicrobial uses. These products may or may not contain antimicrobials, and their use could delay treatment for serious illnesses.
  • The FDA has determined that many of these products mimic the labeling of drugs available in Mexico, and that they are marketed specifically to the Hispanic community.
  • Consumers should stop using these products immediately and contact their health care providers.

  • What is the Problem?The FDA has determined that several companies are marketing products that look like antimicrobial products available in Mexico. Consumers using the products may believe they will receive the beneficial health effects of an antimicrobial drug. These products may or may not contain antimicrobials, and their use could delay treatment for serious illnesses.  These products are not FDA approved to treat, cure or prevent any medical conditions.

    What are the Symptoms of Illness/Injury?Consumers may be using these products under the belief that they contain antimicrobials. Doing so may cause worsening of existing illness and delayed treatment. An antimicrobial is a substance that kills or inhibits the growth of pathogens such as bacteria, viruses and fungi.

    The FDA is aware of at least four cases in Texas in which children received emergency care due to worsening illnesses after being given products that the parents may have believed contained antimicrobials. These products were packaged to resemble antimicrobial drugs that are readily available in Mexico.  It was determined the children had been given a product, Amoxilina, which the parents may have believed was the antimicrobial Amoxicillin. Giving the product to the children delayed legitimate medical treatment.

    Who is at Risk?All consumers are at risk. Although package labels are printed in English and Spanish, the packaging mimics antimicrobials readily available in Mexico and possibly familiar to Hispanic consumers. 

    What Do Consumers and Health Care Providers Need To Do?  

    Consumers who have been using these types of products should consult their health care providers immediately. Consumers should be skeptical of any product that claims to be a dietary supplement and claims to treat, prevent or cure disease or contain an antimicrobial.

    Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

  • Online:
  • Regular Mail: Use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
  • Fax: 800-FDA-0178
  • Phone: 800-FDA-1088

  • What Does the Product Look Like? Various companies market these products. The FDA is aware of several products listed below, but this list may not be complete.Product Name


    UPC #

    StatusAmoxilina Capsules 500 Mg (30 Caps)



    Voluntarily recalled  05/06/2011Amoxilina Suspension (3.4 Oz)



    Voluntarily recalled  05/06/2011Pentreximil Plus 500 Mg (30 Caps)



    Voluntarily recalled  05/06/2011Pentreximil Plus Syrup 3.4 Oz



    Voluntarily recalled  05/06/2011Pentrexyl Forte Natural, 30-capsule box containing capsules in blister packs

    Phoenix Import & Distribution

    8 93843 00129 3

    Voluntarily recalled 05/12/11Where is it Distributed? The products have been distributed in Colorado, Delaware, Texas, Florida, California, Georgia, and potentially other markets. The products are marketed toward Hispanic consumers. They may be sold at various retailers, including small independent stores that cater to the Hispanic community.

    The information in this press release reflects the FDA's best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.

    For more information:

    Drug Claims Prompt Health Alert:

    Multi-Mex Recall Notice:

    Phoenix Recall Notice:

    Beware of Fraudulent "Dietary Supplements":

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


    Visit the FDA on Facebook

    RSS Feed for FDA News Releases [what is RSS?]

    Media Inquiries: Tamara Ward, 301-796-7567 (Office) 240-479-8003 (Cell)

    Consumer Inquiries: 888-INFO-FDA


    SOURCE U.S. Food and Drug Administration
    Copyright©2010 PR Newswire.
    All rights reserved

    Related medicine technology :

    1. Dr. Haroun Rostami, a Beverly Hills Prosthodontist, Provides Patients with Metal-Free Dentistry Treatments
    2. New Study Published: Lactobacillus reuteri Prodentis Effective in the Treatment of Periodontitis
    3. OrthoAccel Technologies Committed to Plans for Positioning the United Kingdom as a Key Strategic Market for New Orthodontic Technology
    4. OrthoAccel Technologies, Inc. and AB Orthodontics Announce Partnership and Australian Product Introduction
    5. Imagenetix Announces Issuance of New U.S. Patent for the Prevention and Treatment of Periodontal Disease
    6. Cell Therapeutics to Re-submit Pixantrone NDA in Consideration for Accelerated Approval in Accordance with Guidance from FDAs Office of New Drugs
    7. Dramatic Price Increases in Brand Name Drugs Spur Shareholders to Action
    8. Reportlinker Adds Orphan Drugs in Asia: Guidelines and Regulatory Requirements to Help Orphan Drug Products Enter the Asian Market 2011
    9. Fisher Center Scientists Show That Anti-Inflammatory Drugs Reduce Effectiveness of SSRI Antidepressants
    10. Bend Research Receives Patent for Technology That Enhances the Bioavailability of Low-Solubility Drugs
    11. Dainippon Sumitomo Pharma Co., Ltd. and Boston Biomedical, Inc. Enter Strategic Partnership on Anti-Cancer Drugs Targeting Cancer Stem Cells
    Post Your Comments:
    (Date:11/30/2015)... , Nov. 30, 2015 Nevro Corp. (NYSE: ... providing innovative evidence-based solutions for the treatment of chronic pain, ... at the U.S. Patent and Trademark Office (USPTO) has denied ... Patent No. 8,359,102 (the ,102 patent).  ... unit of Boston Scientific Corporation filed two petitions challenging the ...
    (Date:11/30/2015)... , Nov. 30, 2015 ... the "Orphan Drugs Market 2015-2019" report ... has announced the addition of the "Orphan ... --> Research and Markets ( ... "Orphan Drugs Market 2015-2019" report to their ...
    (Date:11/30/2015)... global cell culture market is expected ... bn by 2022 at a CAGR of 7.1% therein. --> ... its 2013 value of US$6.1 bn to US$11.3 bn by 2022 ... Research has announced the release of a new market research study, ... ,Cell Culture Market - Global Industry Analysis, Size, Share, Growth, Trends ...
    Breaking Medicine Technology:
    (Date:11/30/2015)... Atlanta (PRWEB) , ... November 30, 2015 , ... Using ... detection of prediabetes in American children and adults, according to a new study by ... Improving Detection of Prediabetes in Children and Adults: Using Combinations of Blood Glucose Tests ...
    (Date:11/30/2015)... ... ... Newly reviewed and approved “NJ Top Dentist”, Paul Dionne, ... both advanced training and considerable experience in reconstructive dentistry with attention to occlusal ... He is an active Spear Education member providing full mouth restorative and ...
    (Date:11/30/2015)... ... November 30, 2015 , ... International telepathology consultations ... and KingMed Diagnostics researchers. Their review of more than 1,500 ... UPMC pathologists resulted in significantly altered treatment plans for more than half of ...
    (Date:11/30/2015)... New York, NY (PRWEB) , ... November 30, 2015 , ... ... New York Times,” will be released on December 1, 2015, to coincide with World ... book about the groundbreaking journalist who covered the AIDS epidemic as he was dying ...
    (Date:11/30/2015)... , ... November 30, 2015 , ... ... promoting breast and prostate cancer education and prevention—is joining forces with the award-winning ... philanthropy and Hollywood elegance on December 7, 2015 at the Union League of ...
    Breaking Medicine News(10 mins):